Salarius Pharmaceuticals Inc (SLRX) 2020 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to Salarius Pharmaceuticals Q4 and Year-end 2020 Financial Results Call. (Operator Instructions) Please be advised that today's conference may be recorded. (Operator Instructions)

I would now like to hand the conference over to your host, Jason Rando with Tiberend Strategic Advisors. Sir, please go ahead.

Good afternoon, everyone, and thank you for joining Salarius Pharmaceuticals 2020 Fourth Quarter and Full Year Financial and Corporate Results Call. Earlier this afternoon, Salarius Pharmaceuticals issued a press release detailing its financial results for the 3 months and the full year ended December 31, 2020, which we encourage listeners to read. The press release can be found in the News section of salariuspharma.com. Salarius also filed a 10-K this afternoon, which is available on Salariuspharma.com and sec.gov.

Before beginning today's call, I would like to make the following statement. Today, we'll be making certain forward-looking statements about future expectations, plans, events and circumstances including statements about our strategy, future operations and the development of our lead investigational drug candidate, seclidemstat, and our expectations regarding our capital allocation and cash resources. These statements are based on our current expectations, and you should not place undue reliance on these statements. Actual results may differ materially due to our risks and uncertainties and including those detailed in the Risk Factors section of Salarius Pharmaceuticals 10-K filed with the SEC and other filings we make with the SEC from time to time.

Salarius Pharmaceuticals disclaims any obligation to update information contained in these forward-looking statements, whether as a result of new information, future events or otherwise. With us on today's call is David Arthur, Director and CEO of Salarius' Pharmaceuticals, who will provide an update on spares' corporate and clinical achievements during the fourth quarter and its vision for the future; and Mark Rosenblum, CFO, who will review Salarius' fourth quarter and full year 2020 financial results.

David, please go ahead.

Thank you, Jason. And thank you to everyone joining our conference call today, including all of you who are joining for the first time.

Today's call highlights an exciting time in the growth of Salarius. In just the past few weeks, we have achieved important clinical milestones in the development of our lead drug candidate, seclidemstat. And we have achieved significant milestones in financing so areas.

We have completed the dose escalation portion of the Ewing sarcoma clinical trial and seclidemstat is now being investigated at the recommended Phase II dose in 3 distinct patient populations made up of Ewing sarcoma and Ewing-related sarcomas, which in the case of Ewing-related sarcomas include 2 patient populations made up of myxoid liposarcoma and other FET-translocated sarcomas.

Each of these 3 patient groups Ewing sarcoma, myxoid liposarcoma and FET-translocated sarcomas potentially represents a separate regulatory path to approval and the related commercial opportunity. These recent clinical milestones and the expansion of the Ewing clinical trial to include Ewing's related sarcomas, further underpins and supports the first prong of our development strategy, speed to market.

Salarius is now investigating 3 patient populations, each of which is supported by future clinical results, we believe has the potential for accelerated regulatory approval and supports our strategy of speed to market.

In parallel, I'm very pleased to report that as a result of a series of financial transactions, Salarius now has the capital resources of approximately $37 million in available cash to fund our current clinical trials while providing the ability to develop seclidemstat in larger market indications, including solid tumors and hematologic cancers. These larger market indications represent the second prong of our development strategy, expand the market.

In addition to these clinical and financial achievements, we have also amended the Ewing clinical trial to expand the addressable Ewing sarcoma patient population and improve patient access to seclidemstat earlier in the patient's treatment paradigm.

By combining seclidemstat with the common second or third line chemotherapy treatment, topotecan and cyclophosphamide, we hope to open the door to seclidemstat's potential use much earlier in a Ewing patient's treatment continuum as a second or third line therapy, while improving their patient outcomes.

Let me make sure I clearly communicated the importance of these developments. We believe we have integrated seclidemstat into the Ewing sarcoma standard of care, and seclidemstat can now be easily administered as a second- or third-line therapy in our ongoing clinical trial.

In addition to increasing the number of patients who can receive seclidemstat treatment, we believe that this also makes it easier for physicians to utilize seclidemstat early in the Ewing sarcoma continuum of care, while potentially improving patient outcomes.

Finally, in a small subset of Ewing-related sarcoma patients with relapsed or refractory disease, that enrolled in the advanced solid tumor trial, all patients in the subset showed indications of seclidemstat drug activity as evidenced by a medium-timed progression that was greater or longer than a benchmark commonly used for single-agent activity in this advanced relapsed soft tissue sarcoma setting.

It is important to note that these indications of drug activity occurred at doses below the recommended Phase II dose that we are currently using in our ongoing Ewing and Ewing-related sarcoma trials.

Again, to be clear, in a small subset of patients with relapsed or refractory Ewing-related sarcoma, we observed a median increase in the patient's time to progression when compared to a benchmark commonly used for single-agent activity in the advanced relapsed soft tissue sarcoma setting.

We believe this is exciting preliminary data of seclidemstat activity in Ewing-related sarcomas. I cannot understate our view regarding the importance of these developments to the ongoing growth of seclidemstat and Salarius, nor can I understate how well we believe this positions Salarius for the future.

Mark and I look forward to speaking in detail about each of these accomplishments later in the call. However, before that, I would like to take a moment and provide my thoughts on the past 12 months.

If you had asked me a year ago, if Salarius would be in the position of strength that we are now in, I would have responded with a resounding, absolutely.

Why would I have said that? Because we had a well-defined strategy, and we executed on a plan that I fully expected will yield positive results.

Of course, this plan did not factor in the COVID-19 pandemic. In just a matter of days last March, the world was impacted by a once-in-a-generation situation. Salarius was not immune. But in spite of the many uncertainties, we were able to quickly make adjustments that enabled us to persevere in certain ways, become stronger as a company.

This type of fortitude was especially evident in those who led and participated in our clinical trials, including our clinical development team, the investigators and staff at our cancer centers that are implementing our clinical trials and most importantly, the trial participants and their families who selflessly volunteered their time and energy despite these many challenges.

For the patients with advanced cancers participating in our clinical trials, everyday activity suddenly became an even greater ordeal. Yet these patients were willing to participate in our trials so that we could continue developing seclidemstat to all the past and current participants in our trial, we thank you.

Later in today's discussion, I'll talk more about the positive impact of our recent clinical and financial milestone achievements and our plans to continuing developing seclidemstat for larger market indications, including solid tumors and hematological cancers.

But now I would like to hand the call over to our Chief Financial Officer, Mark Rosenblum, who will speak to our fourth quarter and full year 2020 financial results. Mark, please go ahead.

Thank you, David. For the 3-month period ended December 31, 2020, Salarius reported a net loss of $1.8 million or $0.10 per basic and diluted share compared to a net loss of $1.9 million and $0.46 per share in the fourth quarter of 2009.

For the full year, Salarius reported a net loss of $7.4 million and $0.50 per basic and diluted share versus a loss of $6.9 million or $2.12 per basic and diluted share for the prior year.

The loss from operations before other income for the 3 months ended December 31, 2020, decreased by $0.3 million compared to the loss from operations of overall $2.1 million for the same time spend last year, which was primarily due to an increase of $0.4 million in grant revenue and lower general and administrative costs, more than offsetting higher research and development expenditures.

Increased research and development costs resulted from increased drug manufacturing costs. The decrease in general and administrative costs resulted from the absence of expenses related to Salarius' onetime transformation into a public company during 2019, which did not reoccur in the current period. This offsets higher personnel costs in the current period.

Our December 31 balance sheet states the company had $11.1 million in cash and cash equivalents. The balance sheet was strengthened in early 2021 as the company raised over $30 million from both the sale of our common stock and underwritten public offering and warrants exercises.

We also received $0.9 million in nondilutive CPRIT financing during Q1 2021. Salarius has an additional $4.8 million under the CPRIT grant, and we expect to receive a portion of that amount in 2021. The results of these funding activities is that Salarius has currently available cash of approximately $37 million, our strongest financial position to date. We believe Salarius has the financial resources available to advance our ongoing clinical trials through completion and beyond.

With that, I'd like to return the call to David.

Thank you, Mark. As we have discussed, our goal as a company is to maximize the potential of seclidemstat, and by doing so, bring hope to patients and their families facing limited treatment options, while creating and building shareholder value.

To that end, I would like to state that by midyear 2021 this year, we hope to have active clinical trials across 5 separate patient populations, evaluating seclidemstat as single-agent therapy and in up to 3 different combination therapies.

As discussed earlier, completing the dose escalation stage of our Ewing sarcoma clinical trial is a major achievement. The primary purpose of the study was to determine the safety and tolerability of seclidemstat with secondary endpoints to assess the maximum tolerated dose, determine the recommended Phase II dose and measure antitumor activity, pharmacokinetics and pharmacodynamics.

I am pleased to report that the dose escalation stage succeeded. Data demonstrated that seclidemstat has a manageable safety profile. The recommended Phase II dose for the expansion stage has been established.

And importantly, pharmacokinetic data indicated that treatment at the recommended Phase II dose achieved human plasma concentrations above levels where seclidemstat demonstrated activity in preclinical or animal studies.

We believe the data from this dose escalation trial is compelling. And for this reason, Salarius has submitted the full findings, including details on safety, dosing and initial efficacy signals for presentation at an upcoming oncology conference.

Once the conference embargo lifts, we will be able to provide more detailed information. Again, please allow me to reiterate because it is important to state clearly. The dose escalation stage of the trial achieved all key endpoints. It demonstrated seclidemstat safety profile established a recommended Phase II dose, and we believe it provided early evidence of drug activity.

Although our dose escalation trial is primarily focused on establishing seclidemstat's safety, we believe, as we've stated, we observed preliminary evidence supporting seclidemstat's potential to treat advanced-stage cancer patients.

Notably, these observations occurred in patients primarily treated at doses below the recommended Phase II dose in patients that were heavily pretreated with multiple prior treatment failures, and in patients who had relapsed or refractory disease upon enrollment.

This preliminary evidence of drug activity was observed in a refractory Ewing sarcoma patient who is treated with single-agent seclidemstat for 6 28-day cycles and demonstrated more than a 75% tumor reduction in prospectively defined some of target lesions.

However, despite this significant tumor reduction, a new non-target lesion appeared at the end of cycle 2, resulting in a classification of progressive disease as defined by response evaluation criteria in solid tumors, version 1.1 or RECIST 1.1.

Having said that, Salarius believes this data demonstrates preliminary single agent drug activity in a patient with refractory Ewing sarcoma, meaning disease, which had failed prior medical treatments responded to seclidemstat as single-agent therapy. This is especially encouraging, given the challenge in treating refractory disease and the fact that the patient received no other cancer treatment while taking seclude stat.

Given the preliminary evidence of drug activity observed, Salarius believes there is a meaningful opportunity to introduce seclidemstat earlier in the Ewing sarcoma continuum of care, which we believe will benefit patients and increase the addressable Ewing sarcoma patient population.

Internal preclinical research suggests that Ewing sarcoma cell lines, seclidemstat has an additive effect, an additive effect when combined with the chemotherapy agents, topotecan and cyclophosphamide. This suggests the seclidemstat can be added to topotecan and cyclophosphamide and potentially improve upon current patient outcomes.

Additionally, because topotecan and cyclophosphamide de are commonly used as second or third line treatment. Salarius can potentially increase the addressable patient population for seclidemstat by supporting doctors and patients use of seclidemstat earlier in the treatment paradigm.

Based on these conditions, Salarius considerations, Salarius amended the dose expansion trial protocol so that Ewing sarcoma patients who have failed 1 or 2 prior lines of therapy may be treated with seclidemstat in combination with topotecan and cyclophosphamide as second or third line therapy.

This is an exciting development and one that aligns perfectly with our goal to increase our use of seclidemstat by exploring its potential as a treatment for a broader patient population.

In addition to the Ewing sarcoma news, we believe we have seen encouraging clinical data from a small subset of Ewing-related sarcoma patients enrolled in the Salarius advanced solid tumor trial.

All patients in this subgroup had relapsed or refractory disease when enrolled in the trial, and all patients in this subset demonstrated signs of drug activity despite being treated with seclidemstat at doses below the recommended Phase II dose.

Patients in this subgroup exhibited a median time to progression longer than a commonly-used benchmark for assessing single-agent activity in this advanced relapsed soft tissue sarcoma setting. This is exactly -- and I want to repeat, this is exactly the type of data we were hoping to see to support seclidemstat's potential to treat these difficult Ewing-related sarcomas and move forward with our strategy to expand in new patient populations, establish new potential paths to regulatory approval and pursue the related commercial opportunities.

Salarius has now initiated the dose expansion stage of the Ewing and Ewing-related sarcoma trial, which was expanded to include up to 30 patients with relapsed or refractory Ewing sarcoma as well as up to 30 patients with sarcomas that share a similar biology to Ewing sarcoma. I've referred to these as Ewing-related sarcomas or FET translocated sarcomas.

These Ewing-related sarcoma patients or patients with myxoid liposarcoma and other FET translocated sarcomas will continue to be treated with single-agent seclidemstat and represent completely new addressable patient populations, each with the potential path regulatory approval and a potential commercial opportunity.

The dose expansion portion of the Ewing and Ewing-related trial will continue to evaluate safety and antitumor activity in all participants with preliminary data readouts expected towards the end of 2021 and 2022.

Salarius has also submitted findings from the advanced solid tumor trial, including details on safety, dosing and initial safety signals for presentation at an upcoming medical conference. Once the conference embargo lifts, we will be able to provide even more information.

In summary, we believe the clinical data collected thus far from the Ewing sarcoma trial and the ongoing advanced solid tumor trial has demonstrated that seclidemstat has a manageable safety profile, can be administered at doses that are clinically relevant, and we believe has provided evidence of drug activity in patient populations with advanced disease.

We believe that the clinical progress discussed today paints a promising picture of seclidemstat's potential as both a single agent and combination therapy for patients with hard-to-treat cancers in need of better treatment options.

Salarius and our clinical investigators are excited about the potential of seclidemstat to treat Ewing sarcoma patients earlier and the potential to treat these additional Ewing sarcoma patient -- Ewing-related sarcoma patients.

In addition -- and additionally, we believe there is a substantial unexplored potential ahead for seclidemstat, and we anticipate even more opportunities in 2021 to justify the use of seclidemstat in other underserved cancers.

In that regard, Salarius has completed much of the necessary work to begin clinical trials in other cancer indications that align with seclidemstat's mechanism of action, and we look forward to announcing these trials in the near future.

Areas of interest we have previously discussed include hematologic cancers and the use of seclidemstat in combination with immuno-oncology therapies, specifically checkpoint inhibitors.

Checkpoint inhibitors are a class of immunotherapy treatment designed to unleash a human immune system attack on cancer cells. However, these drugs do not work in all cancer patients or in all cancer types.

In addition, patients do not show an initial -- in addition, patients that do show an initial response can become resistant to the checkpoint inhibitor treatment and experience a return of the disease, commonly known as disease relapse.

Interestingly, data from preclinical studies conducted by the Translational Genomics Research Institute in Phoenix, Arizona, and published in the peer review journal plus 1 last year demonstrated the potential of using seclidemstat in combination with checkpoint inhibitors to overcome cancer's ability to hide from the immune system and thereby unleash the immune system to attack the cancer.

In simple terms, seclidemstat may turn tumors concealed from a patient's immune system called cold tumors, into hot tumors, our tumors, the immune system is able to identify and infiltrate.

These now hot tumors could then respond to treatment with checkpoint inhibitors. This provides a significant opportunity for seclidemstat because it could be used to treat patients with a wide variety of cancers that are currently unresponsive to checkpoint inhibitors.

As I said earlier, considering the data we have generated to date and the potential for additional data generation in ongoing clinical programs and soon to be announced additional clinical programs, these are exciting times for Salarius.

Again, by midyear 2021 this year, we hope to have active clinical trials across 5 patient populations, evaluating seclidemstat as single agent therapy and evaluating seclidemstat in up to 3 different combination therapies.

I would now like to take questions. Joining me for the Q&A portion of this call is Mark Rosenblum, Chief Financial Officer; Dr. Nadeem Mirza, Senior Vice President of Clinical Development; and Dr. Daniela Santiesteban, Director of Corporate Development.

With that, I will now open the call to your questions.

(Operator Instructions) Our first question comes from the line of Wangzhi Li of Ladenburg.

And thanks for the comprehensive update and summary in creations on all the progress. My first question is read into the expansion cohort, the Ewing-related sarcoma. You mentioned the 2 different patient population, myxoid liposarcoma and other sarcoma. Just want to clarify, is there a number of patient allocation for these different type of sarcoma or just a mix?

Thank you for the question. Dr. Mirza, would you like to take that?

Yes. So yes, we have allocated around 10 to 15 for myxoid liposarcoma and around 10 to 15 in other FET-translocated sarcoma patients. And the reason being so that we could -- we are able to see a clear signal of activity.

Got it. And the reason you think about is Max loyal liposarcoma, is it based on the myxoid liposarcoma you saw from the dose escalation portion?

That's correct. In our advanced solid tumor, that is still undergoing dose escalation. We have observed -- we have seen -- we have observed a good signal and for reasons of confidentiality and the fact that we have submitted this to an upcoming oncology conference.

I can't go into details, but we have seen a strong signal in patients and based on that, these additional 10 to 15 patients will supplement that signal. And so we should be able to get a very strong signal for further development or in fact, potential discussion with health authorities on the next steps.

Got it. It's helpful. I know you're under embargo for the conference presentation, but any color on what should we expect in terms of number of patients or what kind of data and timing is at the conference later this year? Any further color you can even share?

Yes. Unfortunately, the embargo is quite broad. We can't discuss or disclose anything that was submitted in the abstract. And I apologize, I won't be able to...

Got it. No problem. Yes, yes, I understand. I mean then maybe shift gear to -- you are going to have multiple trials ongoing later this year. And just -- and of course, you have a strong balance sheet. Just any color on what time -- for what kind of stage the current cash can fund all these trials through with completion of this -- mid of those trials?

And I understand there are 2 trials that will be investigated sponsor, so maybe customized.

And any color on the cash runway relating to the completion or progress of other trials?

David, would you like to take that?

Actually, Wangzhi, thanks for the question. I'm going to toss that one to Mark because he is the master of our recent financial transactions and is managing our $37 million in available cash. Mark?

Thanks, Wangzhi. We get the tag team because I'm sitting right next to David. So really, the way we look at it, Wangzhi, is we're going to have some readouts, probably at the end of Q4, certainly in Q1 2022. And at that time, we will have substantial cash available to -- first of all, we'll have substantial cash available to complete all the clinical trials that we're currently conducting.

And then when that information takes us to a place that says we are -- we have several different trials on the board. So we won't discuss what they are. But when we make the decision to pivot to a particular trial, we'll have sufficient cash to make great headway into whatever trial we select to use.

And that -- so we're in very good shape right through the end of 2021, really well past 2022 as well. This recent cash raise really set us in a different position.

A frequently asked question is, do you guys have sufficient capital to complete the trials that you're currently conducting?

When we have non-deal road shows, when we have investor roadshows, that's a very common question. You guys have sufficient cash to complete the plan you're currently on. And now we can say emphatically, yes, we do. So I hope that helps you.

Our next question comes from the line of Aydin Huseynov of Benchmark Company.

Congratulations with the strong quarter and actually the strong year. So I just wanted to go back to Ewing sarcoma and Ewing-related sarcoma trial. So you have a combo with chemotherapy in second and third line, and then you have a single agent for Ewing-related sarcomas in the third line.

So why did you decide not to combine Ewing-related sarcomas with chemo, just like you did with you and Ewing sarcoma itself?

Nadeem, would you like to take that one?

Yes, sure. It's a very valid question. So for the myxoid liposarcoma, there is -- there are 2 drugs that are currently approved. What we have observed in these patients as a single agent that those patients have failed those standard treatment and still had significant clinical activity. So we want to further established single-agent activity for the myxoid liposarcoma.

And if we are able to show what we observed in the preliminary, I think it will be a relatively a good path to regulatory approval as a single agent. We do have some internal discussions have been going on. So we are looking at further combinations as well, but we're not ready to disclose them at this time. Regarding the FET translocation to sarcoma, there is no standard treatment for those patients.

So -- and these patients are treated with different chemotherapies and a different regimen. So it will be difficult to select a single or a couple of chemotherapy regimens that one would want to combine with.

And among those patients in the fat translocated patients who had failed multiple lines of prior treatments, chemotherapies and other agents, we have observed a significant clinical activity as a single agent and following the same logical path of thinking if we can show similar activity in additional patients that would be regulatory -- potential regulatory path for approval for a single agent.

Right. Appreciate that. And -- yes, you did. I just wanted to follow-up on that. So what do you see there as a success. Where does -- can you remind us what the standard of care stands for those 2 kind of groups of patients?

Second third line in sarcoma and kind of third line plus Ewing-related sarcoma. Is there kind of ORR specific number? Or is there overall survival number that you're targeting?

Yes. So I cannot disclose what we are aiming for what we observe, but I can tell you what the benchmarks are for Ewing sarcoma. The benchmark is around 5 to 6 months median PFS. For myxoid liposarcoma, in earlier lines of patients, now I remember, we have patients that have failed with standard treatment but in myxoid liposarcoma, the range of median PFS is around 3.5 to 4 months. That's the median PFS.

For FET translocated sarcoma, as I mentioned, there's no clear good benchmark, but what we have observed when we looked at the literature, it averages around median of 2 to 3 months. And in our study, we have seen much, much significant prolongation of these progression-free survival time point.

Apologies, again, I'm going to probably go a little bit different that, but do you envision able to pathway as a single-arm study in any of those Ewing-related sarcoma cohorts of trials?

Well, yes, that will be a discussion with the health authorities. Based on those patients have exhausted all treatment options, if these patients represents a highly unmet need, and I think that regulators would take a view of that and when you present them with the data, showing that these patients have failed either standard treatments available or de facto standards that people use currently.

And once they have failed those treatments and yet single agent, seclidemstat provides additional benefit in terms of prolonging their time to tumor progression, I would certainly hope that the regulators would take that into account for potential approval.

Okay. All right. And for advanced solid tumors, are there indications that you see as the most promising in your opinion for seclidemstat? And are you planning to apply biomarker-based kind of selection work forward in the Phase II?

Daniela, would you like to comment on biomarkers and what we're currently reviewing?

Yes. Happy to. So in our advanced solid tumor trial, we did enroll, as you know, these Ewing-related sarcoma patients. And based off the signal mentioned by David and Nadeem, is why we're now expanding the Ewing sarcoma trial to include these additional patients.

So already, the FET solid tumor trial has given us an indication of patients that may respond better to seclidemstat.

In addition, we're conducting preclinical work to identify if there are sensitizing mutations to seclidemstat. That work is ongoing, and we hope to report results in the next few months.

All right. I appreciate that. And another question I have -- sorry, this is the last one. About the -- you mentioned the additive effect of chemotherapy and are you planning to share that data?

Are you planning to publish that data? And if there is additional -- there is additive effect to chemotherapy, why wouldn't you try all the trials with chemotherapy instead of trying -- as a single agent?

So Daniela, why don't you start with the internal additive data and our plans to offer that and additional work, and then I'll address the second part of the question.

Yes, happy to. So we have done in vitro experiments, combining the chemo regimen, topotecan and cyclophosphamide with seclidemstat and seen additivity. The mechanism there is topotecan and cyclophosphamide or DNA damage agents and LSD1 has been implicated as well in the DNA damage response.

And it may also expose more DNA through its chromatin reconfiguration to the effects of DNA damage and agents. So we feel quite strongly about combining with topotecan and cyclophosphamide from a mechanistic point of view.

But then also importantly, our safety profile does not have significant overlapping toxicity concerns with the chemo regimen, which means that moving forward in clinic, that's a good strategy as you don't have those overlapping talks concerns.

And I'll let David mention why we're taking the strategy of continuing to pursue single agent and some of the other Ewing-related sarcomas before combining with chemo?

So Aydin, thanks for the question. The short answer is we have not taken anything off the table. We're going to follow the science and always try and do what's in the best interest of achieving the most positive in outcomes.

So where we are now with the myxoid Ewing-related sarcomas, is we're following the results that we observed in the subset of patients. And we're fortifying those results with greater patient numbers. And by continuing in single agent therapy, as Nadeem mentioned earlier, if we see results that we're hoping to see, we could have potentially both a single agent and a combination therapy approach to treating those types of Ewing-related sarcomas.

While this is going on, our -- we're working here in our lab internally to identify what chemotherapy agents might be the best combination choices should we decide and head that direction.

So looking back to my how I started the answer to the question, we're keeping all options on the table. But right now, we like the fact that we're pursuing single agent therapy and see where that takes us, which sets up the option of having in a number of directions in the near future.

Our next question comes from Hunter Diamond of Diamond Equity Research.

Firstly, great presentation. I think one of the best ones I've heard from you, David, and the management team and a lot of positive developments.

My question relates to what do you view as the potential of seclidemstat in hematological malignancies? And what that is sort of driving that?

Hunter, thanks for the question. Daniela, would you like to take that?

Yes, happy to. Thanks for the question, Hunter. So LSD1 as a target has been well-validated for hem malignancies due to LSD1's role in blocking differentiation and then driving malignant cell growth. And we've seen other companies with LSD1 inhibitors showing clinical proof-of-concept in hem indications, specifically in AML.

At Salarius, what we've done is we studied seclidemstat in a variety of heme malignancies, AML, myelodysplastic syndrome. And we've seen that seclidemstat has an antiproliferative effect and also that it shows synergistic effects when combined with a commonly used agent in the space, azacitidine.

And then as we mentioned before, one of the benefits of seclidemstat is that we have a manageable safety profile, and we have not seen significant heme talks that some of these other LSD1 inhibitors will often face in clinics.

So we think the combination of our activity in the preclinical model, coupled with our advantage in terms of more manageable heme safety profile will give us an advantage in pursuing seclidemstat within the hematological malignancy indication.

And we're looking forward to formally announcing a trial in the space and initiating that trial in the next few months.

Great. Thank you very much, Daniela, for the update. So my next question is maybe more high level. Obviously, the company is in the best financial position since we've covered the company and in its history, and it has, as you stated money for existing trials. I guess I'm just trying to understand -- and I don't know how much you can comment on this.

Obviously, you're very positive, as stated on the prospects of each subpopulation populations. How do you view the company as sort of -- are you looking at -- and I know I may have asked this before, but are you looking at sort of other assets to acquire at this point? Is it more of stuff would come inbound?

Or do you think there's just so many sort of prospects for a smaller public company at this point that you're just trying to advance sort of these new indications that you already have this quarter?

So Hunter, thanks for the question. The answer is, I'm constantly looking at all areas that will first support the development of seclidemstat and ensure that we are maximizing its potential for patients and ultimately, shareholders. We're -- we want to do is best for patients and create value for shareholders.

Now having said that, we're approached constantly by other organizations that have seen our ability to develop assets and advance them. And they want to talk to us about potentially assisting with their assets and moving them forward. So we take a lot of calls, we take a lot of meetings and I can't comment or commit one way or another of what might happen in the future.

But first and foremost, it's all about seclidemstat. And -- but if the right opportunity were to come along to increase the pipeline. We'd certainly evaluate that opportunity with full force.

Absolutely. Yes. No, I'm just thinking very high level because, as you know, there's only sort of a few companies where you play in epigenetics, right? I mean, you can almost count them on a hands, public companies that have access to funding.

So I would think -- I guess what I'm hearing is generally, you're feeling that there are a lot of opportunities if and when if something arises? It seems like it's a great time to be in the epigenetics market as a whole.

I think it's an outstanding time. It's even better than great. It's an outstanding time. We have a genetic deal. There's -- there are a lot of companies that are developing other epigenetic drugs going after other targets. I think in the LSD1 space or the LSD1 inhibitor space, we're really well positioned. There are other companies that have recently announced preclinical programs in the LSD1 space.

Many of them are pursuing reversibility in their LSD1 inhibitor. So everything we're seeing at a high level indicates that we're heading in the right direction, and we just want to head down that path as quickly as we can.

Absolutely. Yes. No, in this call, it really affirms, I mean, sort of the direction. And I think the strategies are advancing.

At this time, I'd like to turn the call back over to Salarius' CEO, David Arthur, for closing remarks. Sir?

Thank you. Hopefully, what you've heard me say 2 or 3 times is that Salarius has never been on a stronger footing than it is right now, operationally, clinically and financially.

We entered 2021 and with a great deal of momentum. And now we have the resources to maintain that momentum as we advance and we hope to continue to expand our clinical programs and continue the development of seclidemstat.

And as I mentioned earlier, hopefully, what you have seen or heard, as I have gone through today's review, is that I've painted a very positive picture of what we think the future could look like.

I'd like to thank our employees for their dedication and loyalty and for our stakeholders for their continued support as we continue to work to bring hope to patients and their families battling these devastating cancers that we believe are well suited to treatment with seclidemstat.

I appreciate your time and attention today, and I would like to extend my sincere wishes of good health to all. Thank you, and I look forward to talking in the future. Take care.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.